Dynamic Hormone Diagnostics in Endocrine Disease
NCT02934399 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 528
Last updated 2023-11-15
Summary
The study will investigate 27 hour profiles of hormones in the subcutaneous tissue of healthy subjects and patients with Addison's, Congenital Adrenal Hyperplasia, Growth Hormone Deficiency, acromegaly, Cushings and Primary Hyperaldosteronism during conventional diagnostic and therapeutic follow-up.
The 27 hour monitoring by ULTRADIAN takes into account the rhythm of hormones throughout the day. It is hoped that this information may in the future improve and simplify diagnostic procedures. Follow-up of patients in endocrinology still remains difficult including clinical signs of over and under-treatment, questionnaires of quality of life and blood testing necessitating often retesting. Simplification of the diagnostic procedure by obtaining detailed knowledge about the rhythm of hormones may contribute to the improvement and individualization of treatment and may decrease morbidity and mortality of endocrine patients.
Conditions
- Adrenal Insufficiency
- Congenital Adrenal Hyperplasia
- Cushing Syndrome
- Growth Hormone Deficiency
- Acromegaly
- Primary Hyperaldosteronism
Interventions
- OTHER
-
27 hour subcutaneous fluid sampling
One hour prior to the microdialysis catheter insertion the participants will be asked to receive a local anaesthetic on the injection site for the microdialysis catheter. Lignocaine 1% will be injected subcutaneously at a localised site on the abdomen covering a horizontal area of about 5cm after a brief acclimatisation period at the hospital. A sterile linear catheter will be inserted using aseptic precautions at the anaesthetised site on the abdomen. The catheter is connected at one end to the microdialysis pump, and at the other end to the automated collection device. Subcutaneous tissue microdialysis samples will be collected regularly for the duration of the sampling period (27 hours).
Sponsors & Collaborators
- collaborator OTHER
-
University Hospitals Bristol and Weston NHS Foundation Trust
collaborator OTHER -
Evaggelismos Hospital, Greece
collaborator UNKNOWN -
Haukeland University Hospital
lead OTHER
Principal Investigators
-
Stafford Lightman, Professor · University of Bristol
-
Sophie Bensing, MD phD · Karolinska Institutet
-
Stylianos Tsagarakis, Professor · Evaggelismos Hospital
Eligibility
- Min Age
- 18 Years
- Max Age
- 68 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2023-11-14
- Completion
- 2023-11-14
Countries
- Greece
- Norway
- Sweden
- United Kingdom
Study Locations
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